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. 2023 Jan-Dec;15(1):2153410.
doi: 10.1080/19420862.2022.2153410.

Antibodies to watch in 2023

Hélène Kaplon  1 , Silvia Crescioli  2 , Alicia Chenoweth  2 , Jyothsna Visweswaraiah  3 , Janice M Reichert  4
Affiliations

Antibodies to watch in 2023

Hélène Kaplon et al. MAbs. 2023 Jan-Dec.

Abstract

In this 14th installment of the annual Antibodies to Watch article series, we discuss key events in commercial monoclonal antibody therapeutics development that occurred in 2022 and forecast events that might occur in 2023. As of mid-November, 12 antibody therapeutics had been granted first approvals in either the United States or European Union (tebentafusp (Kimmtrak), faricimab (Vabysmo), sutimlimab (Enjaymo), relatlimab (Opdualag), tixagevimab/cilgavimab (Evusheld), mosunetuzumab (Lunsumio), teclistamab (TECVAYLI), spesolimab (SPEVIGO), tremelimumab (Imjudo; combo with durvalumab), nirsevimab (Beyfortus), mirvetuximab soravtansine (ELAHERE™), and teplizumab (TZIELD)), including 4 bispecific antibodies and 1 ADC. Based on FDA action dates, several additional product candidates could be approved by the end of 2022. An additional seven were first approved in China or Japan in 2022, including two bispecific antibodies (cadonilimab and ozoralizumab). Globally, at least 24 investigational antibody therapeutics are undergoing review by regulatory agencies as of mid-November 2022. Our data show that, with antibodies for COVID-19 excluded, the late-stage commercial clinical pipeline grew by ~20% in the past year to include nearly 140 investigational antibody therapeutics that were designed using a wide variety of formats and engineering techniques. Of those in late-stage development, marketing application submissions for at least 23 may occur by the end of 2023, of which 5 are bispecific (odronextamab, erfonrilimab, linvoseltamab, zanidatamab, and talquetamab) and 2 are ADCs (datopotamab deruxtecan, and tusamitamab ravtansine).

Keywords: Antibody therapeutics; COVID-19; SARS-CoV-2; cancer; european medicines agency; food and drug administration; immune-mediated disorders.

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Conflict of interest statement

HK and JV are employed by companies that develop antibody therapeutics. JMR is employed by The Antibody Society, a non-profit trade association funded by corporate sponsors that develop antibody therapeutics or provide services to companies that develop antibody therapeutics, and she is Editor-in-Chief of mAbs, a biomedical journal focused on topics relevant to antibody therapeutics development. Data in this publication were collected from publicly available sources.

Figures

Figure 1.
Figure 1.
Format and number of antibody therapeutics in late-stage clinical studies from 2010–2023*. (a) Format and number of antibodies in late-stage clinical studies for diseases other than cancer (i.e., all non-cancer indications). Antibodies that entered late-stage studies for COVID-19 during 2020–2022 were excluded to enable accurate comparisons to data from previous years. (b) Format and number of antibodies in late-stage clinical studies for cancer. As defined here, ADCs are antibody-derived proteins conjugated to a small molecule drug through a linker, while immunoconjugates are antibody-derived proteins fused or conjugated to any other biologically relevant modality, e.g., protein, radioisotope. Data were derived from the ‘Antibodies to Watch’ articles; data for each article are collected at the end of the previous year. *Data for 2023 is as of October 1, 2022. Abbreviations: ADC, antibody–drug conjugate.
Figure 2.
Figure 2.
Antibody format and engineering strategies in late-stage clinical studies*. (a) Formats for antibodies in late-stage clinical studies for diseases other than cancer (i.e., all non-cancer indications), and (b) cancer indications. (c) Engineering of antibodies in late-stage clinical studies for diseases other than cancer (i.e., all non-cancer indications), and (d) cancer indications. As defined here, ADCs are antibody-derived proteins conjugated to a small molecule drug through a linker, while immunoconjugates are antibody-derived proteins fused or conjugated to any other biologically relevant modality, e.g., protein, radioisotope. Antibodies were included in more than one category if more than one engineering strategy was used in the design of the molecule. *Data as of October 1, 2022. Antibody engineering and format data are included in Supplemental Tables S1 and S2. Abbreviations: Ab, antibody.
Mechanisms of action for antibody therapeutics in late-stage clinical studies*. Two Euler diagrams representing the main mechanisms of action of antibodies in late-stage clinical studies, with mechanisms for the antibodies for non-cancer indications on the left and for cancer indications on the right. The majority of the antibodies for either type of indication function via blocking or neutralization of the targeted antigen. Payload delivery and cell engagement are relevant mechanisms only for the antibodies now being evaluated in late-stage studies as treatments for cancer.
Figure 3.
Mechanisms of action for antibody therapeutics in late-stage clinical studies*. Area proportional Euler diagrams representing the main mechanisms of action of antibodies in late-stage clinical studies. (a) Antibodies for non-cancer indications. (b) Antibodies for cancer indications. *Data as of October 1, 2022; n = 65 antibodies for non-cancer indications, n = 73 antibodies for cancer indications. Abbreviations: CDC, complement-dependent cytotoxicity; ADCC, antibody-dependent cell-mediated cytotoxicity; ADCP, antibody dependent cell phagocytosis. Figure created using euler: Area-Proportional Euler and Venn Diagrams with Ellipses, R package version 6.1.1, available at https://eulerr.co/.
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References

    1. Kaplon H, Chenoweth A, Crescioli S, Reichert JM.. Antibodies to watch in 2022. MAbs. 2022;14(1):2014296. doi:10.1080/19420862.2021.2014296. - DOI - PMC - PubMed
    1. Kaplon H, Reichert JM. Antibodies to watch in 2021. MAbs. 2021;13(1):1860476. doi:10.1080/19420862.2020.1860476. - DOI - PMC - PubMed
    1. Kaplon H, Muralidharan M, Schneider Z, Reichert JM. Antibodies to watch in 2020. MAbs. 2020;12(1):1703531. doi:10.1080/19420862.2019.1703531. - DOI - PMC - PubMed
    1. Kaplon H, Reichert JM. Antibodies to watch in 2019. MAbs. 2019;11(2):219–42. doi:10.1080/19420862.2018.1556465. - DOI - PMC - PubMed
    1. Kaplon H, Reichert JM. Antibodies to watch in 2018. MAbs. 2018;10(2):183–203. doi:10.1080/19420862.2018.1415671. - DOI - PMC - PubMed

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